Pilot study on the determination of intratumoral concentrations of kinase inhibitors in patients with advanced solid malignancies

Pilot study on the determination of intratumoral concentrations of kinase inhibitors in patients with advanced solid malignancies - Intratumoral kinase inhibitor concentrations in advanced cancer patients

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36159

Enrollment

Registered

2011-05-10

Start date

2011-08-01

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

alle vormen van gevorderde, dwz inoperabele of uitgezaaide, solide tumoren Advanced solid tumors metastasized/inoperable cancer

Interventions

Patients will be cohort-wise treated with clinically available kinase inhibitors for 2 weeks prior to standard palliative treatment. Five patients will be included in each of seven drug cohorts. Bio

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Advanced solid malignancy, minimum age 18 years, indication for palliative treatment, measurable disease with at least one lesion accessable for biopsy

Exclusion criteria

Exclusion criteria: Cardiovascular conditions including congestive heartfailure NYHA class >2, recent myocardial infarction or uncontrolled coronary artery disease, cardiac arrhythmias requiring anti-arrhythmic therapy, uncontrolled hypertension; uncontrolled infections; serious non-healing wound, ulcer or bone fracture, pregnant or breast feeding.

Design outcomes

Primary

Measure	Time frame
To determine intratumoral kinase inhibitor concentrations upon 2 weeks of treatment.	—

Secondary

Measure	Time frame
To determine kinase inhibitor concentrations in plasma, serum and PBMC's upon 2 weeks of treatment. To determine intra-dermal kinase inhibitor concentrations upon 2 weeks of treatment. To determine per patient whether 2 weeks of treatment with kinase inhibitors induces significant change of (1) phosphoproteomic profiles in tumor tissue; (2) kinase activity in tumor tissue; (3) markers for antiangiogenic and antiproliferative activity in tumor tissue; (4) serum peptide profiles	—

Measure

Time frame

To determine kinase inhibitor concentrations in plasma, serum and PBMC's upon 2 weeks of treatment. To determine intra-dermal kinase inhibitor concentrations upon 2 weeks of treatment. To determine per patient whether 2 weeks of treatment with kinase inhibitors induces significant change of (1) phosphoproteomic profiles in tumor tissue; (2) kinase activity in tumor tissue; (3) markers for antiangiogenic and antiproliferative activity in tumor tissue; (4) serum peptide profiles

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)